Research

Under the Western Colorado University Policy for the Protection of Human Subjects, all research protocols proposing the use of human subjects must be submitted to the Human Research Committee (HRC) under the Institutional Review Board (IRB) of Academic Affairs. 

The procedure for review has been revised as of July 1, 2023 as outlined below. 

Western Colorado University Human Research Committee is now being supported by the Office of Sponsored Programs (OSP). The process for review has incorporated the use of Sharepoint as a means of collection, communication and storage of applications for review by the HRC. The OSP is managing IRB Sharepoint in collaboration with the Chair of the HRC. 

New forms for submission for a review by the HRC are available on the Human Subjects website under Academic Affairs located below. Old forms will not be accepted by the HRC beginning August 23, 2013. 

Requests for review may be submitted to the HRC (c/o HRC Chair) at any time via email (irb@western.edu). Proposals that require full review by the full board must be received at least seven working days before a board meeting to be considered at the meeting. The scheduled HRC meeting dates are below. 

Anyone submitting a request for review must have completed the CITI training required for Western Colorado University. The information regarding CITI Training and the login information is listed below in Required Training. Information and login for the CITI training is on the Human Subjects website and the OSP website under Academic Affairs. 

All questions can be submitted to the HRC via an email to irb@western.edu, with c/o HRC Chair in the subject line. 

All information provided to the committee must be typed and submitted via email to irb@western.edu as a PDF that contains all the required documents.  Please see the Table of Contents (TOC) checklist that is the first page of the application. Incomplete submissions will be returned without review. Submissions with multiple attachments will be returned with request for proper submission. 

The research investigator must first determine the type of review appropriate for the project and then complete the application. 

A complete submission includes: 

• Table of Contents (TOC) 

• Completed Initial Review Form 

• Consent form(s) 

• Any surveys or questionnaires being used 

• Subject recruitment forms (i.e., posters, email text, verbal script) 

• Grant proposals submitted to federal agencies or private sponsors that require IRB approval 

• Completed CITI certificates for all investigators (including sponsoring faculty and students) involved in the research 

What you will receive from HRC: 

• An email from the Chair of the HRC indicating either approval, approval with modifications, or denial, and a tracking number that must be included in all future email communications with the HRC or IRB. 

• Once approved, any modification of the approved forms must be submitted to the HRC for re-evaluation. 

• Please save all emails and other correspondence with the HRC, all forms, collected data and consent forms for five years in a secure location. 

Following completion of the research, the lead researcher will be required to complete and submit electronically a “Study Closure Form” and all paperwork that includes identifiable information about participants within 30 days of the project end date or April 30 of each academic year. Consent forms and any other data collection artifacts that include names, signatures, photos, video, etc. can be submitted as hard copies mailed to the Office of Sponsored Programs, Attention IRB, Western Colorado University, Taylor Hall 303C, Gunnison, CO  81231. Please include a copy of the Study Closure Form with all hard copies of information submitted. 

Researchers continuing research studies not completed within one year of approval will need to submit a “Continuation Request” for annual review by the HRC per federal guidelines until the study is closed. 

Modifications to an approved study will require the submittal of a “Request for Modification” for review by the HRC before the modification is implemented. 

Fall 

There are three types of review that are performed on research that involve human subjects, depending on the level of risk and whether or not the study fits into certain categories of activities. 

Exempt 

Exempt studies are research activities involving human subjects that are exempt from the federal regulations governing human subject protections. The exemption review process may only be used for research determined to fit within one of the exemption categories defined in 45 CFR 46. 

Exempt studies must still be submitted for review to the HRC. Western has designated the Chair of the HRC as the authorized individual to conduct the review of such studies and determine the exemption. An approval number will be assigned by the HRC to the exempt study and the researcher will be notified within two weeks from submission. Any changes to the study should be submitted to the HRC using the appropriate forms for review so the exempt status can be validated or changed if the study requires a different level of review (expedited or full review) by the HRC committee. 

Expedited 

Expedited review may be used for research that involves no more than minimal risk (as described in one of the federal expedited review categories referenced in 45CFR 46.110 [DHHS] and 21CFR 56.110 [FDA]. When a study is reviewed via the expedited review process only the chair or a designated representative with experience will review the study as submitted. When conducting an expedited review, the reviewer(s) must remember the research in question is subject to 45 CFR 46 and all federally mandated criteria for approval must be met. The researcher will be notified within two weeks from submission via an email of the determination of the submission. Any changes to the study must be submitted to the HRC using the appropriate forms for review so that the status can be validated or if the study now requires a different level of review (full review by the HRC committee). 

Full Committee Review 

Full committee review is required for any research involving human subjects that does not qualify for exempt or expedited review. 

Expedited and full review studies may be granted approval for a maximum of one year. 

It is the intention of Western Colorado University that all individuals engaged in research involving human participants complete an educational program related to the responsible conduct of research prior to initiation of a research project. Effective Aug. 23, 2013, the requirement can only be met by completing the CITI IRB training program. 

The information about how to set up your account and complete training is here, as well as on the IRB/HRC and OSP websites under Academic Affairs. 

Research methods courses and capstone courses at Western require students to complete projects as a way of teaching research methods and skills. Institutional review boards at institutions of higher education vary according to whether they require student projects to be reviewed and approved. The IRB does not require student projects conducted in research methods/capstone courses to be reviewed if the purpose of these projects is educational in nature and will not be published or used in future research. Activities not intended to provide generalizable knowledge are not subject to IRB review. However, the instructor of the course is ultimately responsible for the protection of human subjects. Faculty teaching research methods courses and capstone courses are encouraged to utilize the CITI training as a supplement to the curriculum if HRC review is not applicable. 

Students in graduate methods courses, in particular, sometimes use projects to refine their research interests and provide a foundation for a thesis or dissertation. A project initially conducted to learn research methods may yield data the student subsequently wishes to use to contribute to knowledge. In order to use these data for theses, dissertations or other research purposes, students must either: (1) demonstrate that individuals provided informed consent for the project at the time through procedures approved by the instructor; or (2) obtain consent from the individuals to use previously collected information according to procedures approved by the IRB (i.e. an application for exemption, expedited review or full IRB review). 

Instructors of methods courses requiring student projects not subject to HRC review are asked to submit the Approval and Blanket Exemption (IABE) for Class Research Form via email c/o HRC chair (irb@western.edu).  This form indicates the projects will be conducted under the instructor’s supervision and in accordance with procedures approved by the instructor. The instructor must include the required CITI training for all students in the methods course and provide certificates of completion to the HRC along with required forms in addition to the Instructor’s Approval Form. The HRC Chair will assign an approval number to the exemption and provide notification back to the instructor verifying the student class projects HRC approval. The faculty Sponsor/Instructor of the course is ultimately responsible for the protection of human subjects. Instructors interested in utilizing this approval method are encouraged to contact the Chair of the HRC and discuss the appropriateness prior to submission. 

Student projects in courses are subject to IRB review if they are designed at least partially to provide data for research and publication purposes. For example, instructors may enlist students to assist in data collection or analysis for their own research or may design seminars in which a goal is for students to collaborate in research that will be submitted for publication. These projects constitute research and must be submitted to the IRB for review and receive approval before the project can begin. 

Research conducted by students, such as thesis research and some class projects, requires the approval of the HRC prior to execution. It is the responsibility of faculty supervising research by students or staff to ensure that approval of the HRC Committee is obtained. Individual projects conducted primarily for instructional purposes within the context of a formal class and not designed to contribute to generalizable knowledge do not meet the definition of “research” as defined in the federal guidelines. Thus, they do not require review by the HRC, provided the instructor is prepared to accept professional and ethical responsibility for all research projects conducted in conjunction with the class. Under these conditions, no IRB application need be made and it is the instructor’s responsibility to monitor the ethical propriety of these projects, applying the criteria listed in this document. 

Instructors requiring or sponsoring student projects are asked to send an Instructor’s Approval of Class Research Request Form to the HRC listing the student(s) and their research projects and indicating the projects are being conducted under the instructor’s supervision and in accord with procedures approved by the instructor. The instructor must include the required CITI training for all students and provide certificates of completion to the HRC along with the request. The HRC Chair will provide a notification back to the instructor verifying the student projects did not require HRC approval. The faculty Sponsor/Instructor of the course is ultimately responsible for the protection of human subjects. 

The following clarifications for the guidelines for Student Research and Faculty Responsibility are provided: 

1. Faculty members conducting class-based activities involving human subjects should request HRC review of the activities when there is a chance of public dissemination (i.e. presentation/publication outside of the classroom). In most cases, this can be accomplished by submitting a single request for HRC review of the class project. 
2. Students who are conducting human subject research that will likely be incorporated in a thesis project should submit a request for HRC review. 
3. In rare cases data collected in class-based projects that have not undergone prior HRC approval may be used for dissemination. Petition may be made to the HRC requesting such terms. In this case a statement from the instructor of record must include the specific steps taken during data collection that ensured the ethical conduct of this research. Decisions on these requests will be made on a case-by-case basis. 

The forms below are the newly incorporated IRB forms for the protection of human subjects at Western Colorado University. IRB forms are grouped in three tables below: IRB applications, IRB consent/assent forms, and additional IRB-related forms such as template letters of agreement. Please contact the IRB if you have any questions. 

All submissions must be a PDF document attachment sent via email to irb@western.edu for consideration. Paper copies of the application will not be reviewed. All submissions must be typed. 

Request For Review Forms 

An Institutional Review Board (IRB) is a University committee formally designated to review and monitor research involving human subjects. The purpose of the IRB is to protect, before and during the research study, the rights and welfare of humans participating as subjects in the research.

The IRB has the authority to approve, disapprove, and require modifications to research projects involving human subjects. In addition, the IRB must review and approve or disapprove the investigator for the research. Once approved, the IRB must monitor the progress of the ongoing research and, if necessary, terminate a research project.

The IRB itself is comprised of various scientific experts across Western Faculty who are scientists and non-scientists, and community members outside of the University.

No, you cannot conduct a research study that involves humans before the project has been reviewed and approved by the IRB. The protection of human subjects in research is of paramount importance, and strict adherence to IRB regulations is mandatory. Conducting research without prior IRB approval compromises the ethical principles that govern research and may have exposed participants to unnecessary risks. It also undermines the integrity of the research process and the institution’s commitment to ethical research practices.

Failure to obtain prior IRB approval before research activities are initiated constitutes a significant breach of Federal research regulations and institutional policies and has serious consequences for the faculty advisor.

The federal definition of research involving human subjects is outlined in 45 CFR 46, which states that research is “A systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge”, and it must involve human subjects to comply with federal regulations.

A systematic investigation involves a methodical procedure and plan, is theoretically grounded, and specifies a focused and well-defined research problem or question, is informed by the empirical findings of others, is analytically robust, and provides a detailed and complete description of data collection methods.

Generalizable knowledge is information that is expected to expand the knowledge base of a scientific discipline or other scholarly field of study. Activities designed to contribute to generalizable knowledge are those designed to draw general conclusions, inform policy, or generalize findings beyond a single individual or an internal program. The information is collected to share with others in a discipline and is created to make a broad statement (conclusion) about a group of people, procedures, programs, etc. Generalizable knowledge will yield one or both of the following:

• Results that are applicable to a larger population beyond the site of data collection or the specific human subjects studied.
• Results that are intended to be used to develop, test, or support theories, principles, and statements of relationships, or to inform policy beyond the study.

According to 45 CFR 46, a human subject is “a living individual about whom an investigator (whether professional or student) is conducting research:

1. Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens.
2. • An intervention can include physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or subject’s environment for research purposes.
   • Interaction includes communication or interpersonal contact between the researcher and subject.

2. Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
3. • Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of a participant is associated with the information or may readily be ascertained by the investigator) in order for obtaining the information to constitute research involving human subjects.

Briefly, there are three types of IRB review: convened, exempt, and expedited review.

Convened IRB review is a full committee review where members of the Human Research Committee meet six times per academic year to discuss applications that involve greater than minimal risk, including studies with vulnerable populations and/or sensitive questions, as well as studies with the possibility of physical risk.

Exempt IRB review involves review of research with very minimal risk to human subjects as determined by Federal guidelines. “Minimal risk” means the probability and magnitude of harm are no greater than what people encounter in their daily lives or during routine physical/psychological tests. Studies such as anonymous surveys about non-sensitive topics, observations of public behavior, some research conducted in established or commonly accepted educational settings, or research using existing, de-identified data may be considered exempt studies. These studies still need to be reviewed and approved by the IRB before the study begins. An assigned Human Research Committee member will review these applications.

Expedited IRB review involves studies that pose no more than minimal risk to subjects, but it generally involves activities that might have slightly more interaction or data collection than exempt studies. Examples include collecting blood samples within certain limits, moderate exercise, voice recordings, or studies of existing identifiable pathological specimens. An assigned Human Research Committee member will review these applications.

Not all interactions with humans or data collected from humans are considered research under IRB rules. If your project is not considered research, you do not need to submit an application to the IRB. If your project is considered research under IRB rules, you must submit an application to the IRB and receive approval before research can begin. Applications must be submitted to the IRB for review and approval before data collection begins. This includes proposed research involving, but not limited to, community surveys, interviews, focus groups, teaching practices, existing secondary data, and previously collected human fluid and tissue samples.

Exempt does not mean the study is exempt from review. Exempt refers to specific categories of human research that pose minimal risk to human subjects. Even though an investigator may be certain that a research project classifies as exempt, it still must be submitted to the IRB for review to determine if a study meets criteria to be classified as exempt.

Children are persons who have not attained the legal age for consent (under the age of 18 years) to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.

Assent means a child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.

Children are expected to be part of a discussion about the research and asked if they agree to take part. This agreement to take part in research is referred to as “assent.” While not legally binding, it is expected that a child voluntarily agrees to take part in research that impacts them even if their parent has agreed.

Assent should respect a child’s growing sense of autonomy and ability to voluntarily take part in activities such as research. In general, the IRB expects that assent be obtained from any children 4 or older, unless there are developmental issues that might make this inappropriate.

The assent process should be similar to a consent process, but often has to consider the child’s cognitive capability. Assent, like consent, is expected to be an ongoing process. Even if a child assents and expresses desire to stop at a later point, that decision should be respected, and the child should be withdrawn.

Parent means a child’s biological or adoptive parent. Guardian means an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care. For the purposes of research with unemancipated minors, parental or legal guardian permission can be obtained from: 1: The parent or parents who have custody of the child; 2: The legal guardian of the child; or 3: Any person or judicial or other body authorized by law to provide consent on behalf of the child for participation in human subject research. If permission is from someone other than a biological or adoptive parent, investigators must verify legal guardianship or the legal authority of that individual or other body to provide consent on behalf of the minor.

Permission means the agreement of parent(s) or guardian to the participation of their child or ward in research. “Parental permission” or “consent on behalf of the child” should generally not be shortened to “informed consent,” as “informed consent” refers to an adult giving consent on their behalf. It is encouraged to refer to the process as “parental permission” or “consent on behalf of the child”.

Yes, if the study meets the definition for research with human subjects, as explained above. Western Colorado University’s Federalwide Assurance (FWA) with the U.S. Department of Health and Human Services states that all research being conducted under the auspices of this institution is subject to review and approval by the IRB. Written approval from the IRB must be in place before any interventions or interactions with human subjects (e.g., survey administration, recruitment) actually begin.

Yes, if your research project involves active data collection. IRB regulations require that ALL research involving intervention or interaction with human subjects, regardless of whether or not identifying information is being collected, must be submitted for review prior to beginning the study. If your research involves the use of existing data collected from human subjects (e.g., secondary datasets, existing biological samples), but there are no identifiers linking human subjects to the data/samples themselves, then the activity may not require IRB review and may be considered “not human subject research”. Please contact the IRB Chair at IRB@western.edu for further guidance.

Yes, studies conducted by Western undergraduate and graduate students need IRB approval, if the project fits the definitions of “research” and “human subjects” as described above. If the project is to be used in the classroom setting only to teach research methods (i.e., only intended to meet a class requirement), the project may not constitute human subject research. However, this means that at no point during or after the conclusion of the course can the results or the data be used for publication, presentation, or other research purposes. Therefore, students should discuss these limitations with their instructor or faculty advisor so that they can determine whether IRB review is necessary.

Please note, undergraduate and graduate theses and dissertations are likely to be considered research if human subjects are involved, and will therefore require IRB approval.

You must complete a series of CITI (Collaborative Institutional Training Initiative) training modules to conduct human subjects research. This includes undergraduate and graduate students. To register for trainings, follow the instructions below:

Click on the link for CITI training. Research, Ethics, and Compliance Training | CITI Program

To Register for CITI training, follow these three steps.

1. Click on the Register tab in the top right corner.
2. Click on Select Your Organization Affiliation.
3. Type in Western Colorado University and follow the prompts.

Faculty that conduct human subjects research must complete these trainings:

• Faculty conducting human subjects research
• Western Faculty and Staff responsible conduct of research
• Western Faculty and Staff Conflicts of Interest

Graduate students that conduct human subjects research need to complete the following trainings:

• Western Graduate Students Conflicts of Interest
• Graduate Students Responsible Conduct of Research

Undergraduate students that conduct human subjects research to complete the following training:

• Students conducting human subjects research

Applications must include current certificates showing the above trainings for all members of the research team.

The IRB human research committee schedules six review meetings per the academic year chart shown above.

Yes.

An expedited or exempt review may take about two weeks. Studies requiring a full convened review meeting may take more time depending on the application. The PI has a significant influence on the length of time between submission and approval. Well prepared applications result in fewer requests for changes raised as issues by the IRB. Rapid response by the PI to the IRB issues speeds the approval process.

Some things that may delay approval of your IRB application include submitting an incomplete application by failing to: complete compliance training, cross-checking information on the consent form against information in the protocol, and proofreading the application and relevant documents. Other items that can significantly delay review of your project are shown here: Institutional Review Board (IRB)

To change a currently approved study, the PI must submit a Request for Modification or Addendum to Previously Approved Study to IRB@western.edu. The modification to the study must be reviewed and approved by the IRB before it can take effect.

To end or close your study you should submit a Study Closure Form and send to IRB@western.edu.

Prompt reporting of unanticipated problems/events should occur as soon as possible after the PI learns of the event. Complete and send the Event Report Form to IRB@western.edu.